Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... Read more

Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorneys: Richard D. Kelly and Elissa Sanford
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

Teva Files Certiorari Petition in "Skinny" Label Case

Attorney: Richard D. Kelly
August 9, 2022

On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.<... Read more

The PTAB Weighs in on Obviousness-Type Double Patenting and PTA

Attorney: Richard D. Kelly
May 16, 2022

Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period.  Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue.  The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and MitsubishiMagna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more

Is There Any Hope For Antibody Patents in the United States?

January 25, 2022

Conclusion

Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

Attorney: Elissa Sanford
December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

Biogen v. Mylan: Make Sure Your Patent Applications Cover Your Current R&D

December 1, 2021

Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.<... Read more

THE RECENT HHS' PLAN FOR GREATER FDA – USPTO COLLABORATION TO LOWER DRUG PRICES: WHY PHARMA PATENT COUNSEL NEEDS TO REVIEW FDA SUBMISSIONS

September 22, 2021

In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.<... Read more

The Week That Was In Skinny Labels

Attorney: Richard D. Kelly
August 9, 2021

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.<... Read more

The Federal Circuit Rejects PacBio's Argument that Oxford Used the Then-Emerging Global COVID-19 Crisis to Win on Invalidity for Lack of Enablement

Attorney: Grace Kim
July 15, 2021

In the recent decision PacificBiosciences of California, Inc. v. Oxford Nanopore Techs., Inc., No. 20-2155 issued on May 11, 2021, the Federal Circuit affirmed the district court’s holdings on two important issues, which are particularly of present-day relevance: (1) the influence of the global COVID-19 crisis on the public or jury’s view of the enforcement of intellectual property; and (2) the question of enablement.<... Read more